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Biotechnology and biopharmaceuticals

Complacent or Overly Compliant? Why Has Industry Been Slow to Adopt Single-Use for Bioprocess Control?


A few weeks ago, we hosted a webcast which addressed questions surrounding the relatively slow uptake of single-use technologies for biopharma measurement and control. Speakers Michael Kowolenko (formerly Sr. VP with Wyeth Biotech and Biogen Idec), Kit Erlebach (Merck) and Paul Priebe (Sartorius Stedim) offered a range of perspectives on what has been holding back single-use in biopharma. (A partial transcript is below.

From 'On Pharma'

"Ajaz the Avenger" on the Need for Unity: For PAT and QbD, Pharma Must Learn from Bioprocessing


At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.

From 'On Pharma'

Cell Side Story: Introducing Kenny Twist and D'Na the DNA Girl


North CarolinaIf you're looking for a model of business/government/academic cooperation in preparing the youth of today for careers in biotechnology and the life sciences, look no further than North Carolina. The state has myriad well-funded, integrated programs at the high school and community-college levels in particular.

From 'On Pharma'

Please Take This Survey (and How Many Times Can We Say Thank You?)


In this digital era, we ask a lot more of you, our readers--to answer poll questions, provide feedback on articles, and most importantly to provide input for our surveys on key industry topics. Well, here we go again. There are two surveys that we'd love to get your input on:

From 'On Pharma'

Change: It’s Coming (or “I’ll Get Agile… Mañana”)


Everyone keeps talking about how the industry is on the brink of great change….it’s the death of the blockbuster….the birth of…what?  The niche-buster? Personalized medicine? 

Just keeping up and fire-fighting may be difficult enough so it is tempting to be like Scarlet O’Hara, as in “we’ll just deal with those issues tomorrow.” 

From 'On Pharma'

Chilling Tales of Tech Transfer Gone Terribly Wrong


Am catching up with many things . . . videos and articles from a visit to Wyeth in Pearl River last week, notes and videos (and, yes, they are getting better) from an unusually informative panel discussion at the Emerson Users Exchange meeting in Orlando with FDA’s Helen Winkle and Ali Afnan . . . Look for new updates on our web sites soon.

In the meantime, am in beautiful Raleigh for the Bioprocess International conference, which features an outstanding list of speakers and topics, including tracks devoted to tech  transfer and Quality by Design.

From 'On Pharma'

An iPhone Bioreactor? C’mon, Really?


These past couple months, we’ve been investigating the uses that pharma and life sciences companies will find for iPhones and iPods. Here’s a recent article, including a discussion with Symyx VP of Content Carmen Nitsche on her company's foray into iPhone lab applications, and a blog post on the topic.

From 'On Pharma'

Tauzin on Roche/Genentech Leaving PhRMA: They Feel They Are Different


Hoffman-LaRoche has decided to end its relationship with PhRMA, the industry's largest and most influential lobbying group, in favor of BIO, the biotech industry organization. The move speaks volumes about not just Roche's plans for the future and how it wants to be seen and represented, but also about the ongoing shift of the industry's power base from big Pharma to biopharma.

From 'On Pharma'

Cuba the Next Ireland or P.R.?


An interesting suppostion from writer Clive Thompson on Cuba's potential as a (bio)tech hub. Why not.

 

--PWT

From 'On Pharma'

Notes from BIO 2009: Irish Pharma--Can Innovation and Quality Trump Cost and Infrastructure Considerations?


Some slighting asides were made during one session at BIO, on biopharma capacity...they weren't part of the official powerpoint presentations, but came unofficially during the Q&A, and they showed that some people in the industry may continue to see Ireland as an expensive place to do business.  One wonders whether the speaker was looking only at short term costs.

From 'On Pharma'